FDA Accepts As "Complete Response" Oscient Pharmaceuticals Corporation's Submission Following FACTIVE Approvable Letter For Five-Day CAP
WALTHAM, Mass.--(BUSINESS WIRE)--The U.S. Food and Drug Administration (FDA) has accepted as complete Oscient Pharmaceuticals Corporation’s (Nasdaq: OSCI) response to the FACTIVE® (gemifloxacin mesylate) tablets approvable letter for the application seeking approval for the five-day treatment of community-acquired pneumonia of mild to moderate severity (CAP). FACTIVE is currently approved by the FDA for the five-day treatment of acute exacerbations of chronic bronchitis (AECB) and the seven-day treatment of CAP.